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EC number: 242-354-0 | CAS number: 18472-51-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979-10-19 to 1980-03-17
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- There are some deficiencies in reporting of study details such as pre-acclimatization period, initial age of animals, or preparation of the carcass. Tissue distribution was not studied. Excretion in expired air and in bile was not measured. However, this is not considered to be of major significance for the evaluation of the study. The findings are considered relevant and the present documentation is considered to present valuable information regarding the toxicokinetics of chlorhexidine digluconate.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
- Objective of study:
- excretion
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 417 (Toxicokinetics)
- Deviations:
- yes
- Remarks:
- Some deficiencies in reporting of study details (e.g. tissue distribution was not studied and excretion in expired air and in bile was not measured)
- GLP compliance:
- yes
- Remarks:
- According to ICI’s policies and procedures for GLP
Test material
- Reference substance name:
- D-gluconic acid, compound with N,N''-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine (2:1)
- EC Number:
- 242-354-0
- EC Name:
- D-gluconic acid, compound with N,N''-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine (2:1)
- Cas Number:
- 18472-51-0
- Molecular formula:
- C22H30Cl2N10.2C6H12O7
- IUPAC Name:
- N',N'''''-hexane-1,6-diylbis[N-(4-chlorophenyl)(imidodicarbonimidic diamide)] - D-gluconic acid (1:2)
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- 14C uniform ring-labelled
Test animals
- Species:
- mouse
- Strain:
- other: C57 B1/10J
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
-Source: ICI, Animal Breeding Unit, Alderley Park
-Weight at study initiation: 21-31 g
-Fasting period before study: no
-Housing: animals were housed in pairs in metabolism cages
-Individual metabolism cages: Urine and faeces were collected for 7 days. Cages were washed each day and washings were retained for analysis
-Diet: ad libitum
-Water: ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Duration and frequency of treatment / exposure:
- Animals were dosed once via gavage
Doses / concentrations
- Remarks:
- Doses / Concentrations:
25, 50, 100 or 200 mg/kg bw
- No. of animals per sex per dose / concentration:
- 6 m / 6 f
- Control animals:
- no
- Details on study design:
- Urine and faeces were collected for 7 days. Cages were washed each day and washings were retained for analysis. Animals were sacrificed at the end of the study and carcasses were retained for analysis of radioactivity.
- Details on dosing and sampling:
- Group 1 and 2 (25 mg/kg bw): 4.08 mg 14C-base (preparation 17R), 2 ml water, 2.9 mg 1,5-gluconolactone, 63.6 ul chlorhexidine digluconate (20 % solution), 1.93 ml water to produce 0.5 % chlorhexidine digluconate. 266 ul of the solution were given by gavage.
Group 3 and 4 (50 mg/kg bw): 3.81 mg 14C-base (preparation 17R), 2 ml water, 2.7 mg 1,5-gluconolactone, 166 ul chlorhexidine digluconate (20 % solution), 1.83 ml water to produce 1 % chlorhexidine digluconate. 266 ul of the solution were given by gavage.
Group 5 and 6 (100 mg/kg bw): 1.3 mg 14C-base (preparation 17R) + 3.3 mg (preparation 18R), 3 ml water, 3.5 mg 1,5-gluconolactone, 359 ul chlorhexidine digluconate (20 % solution), 1.96 ml water to produce 1.5 % chlorhexidine digluconate. 355 ul of the solution were given by gavage.
Group 7 and 8 (200 mg/kg bw): 1.8 mg 14C-base (preparation 19R), 4 ml water, 1.3 mg 1,5-gluconolactone, 783 ul chlorhexidine digluconate (20 % solution), 0.54 ml water to produce 3 % chlorhexidine digluconate. 355 ul of the solution were given by gavage. - Statistics:
- no data
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on excretion:
- Urinary excretion at all dose levels accounted for 0.6 +/- 0.1 % of the dosed radioactivity. Urinary excretion over the dose range 25-200 mg/kg bw was 0.55 +/- 0.06 %. There was no apparent dose dependency, although the highest excretion was observed at the highest dose level, but data were derived only from two animals. Faecal excretion amounted to 77.9 +/- 2.7 % of the administered dose. Faecal excretion occurred over several days, possibly due to the loss of appetite. A mean of 94 % of the faecal excretion of radioactivity occurred within the first 3 days.
Analysis of the carcass of the animals from which the lowest recoveries of radioactivity were obtained showed that only 2.2 +/- 0.6 % of the administered dose remained in the body.
Toxicokinetic parametersopen allclose all
- Toxicokinetic parameters:
- half-life 1st:
- Toxicokinetic parameters:
- half-life 2nd:
- Toxicokinetic parameters:
- half-life 3rd:
Metabolite characterisation studies
- Metabolites identified:
- no
Any other information on results incl. tables
Death and loss of appetite for 1 or 2 days following dosing were observed in all dose groups except 50 mg/kg bw. However, the reason for the death of some animals and for the marked differences in sensitivity (ranging from death to no observable symptoms) are unknown.
Applicant's summary and conclusion
- Conclusions:
- The bioaccumulation potential is low based on study results
The data are indicating a low excretion in urine (0.6 %). In combination with a high recovery of chlorhexidine digluconate in faeces and a low recovery in the carcass, the data are indicating that the substance is poorly absorbed from the gastrointestinal tract. - Executive summary:
In this study equivalent to OECD Guideline 417, 14C-uniform ring-labelled chlorhexidine digluconate was administered by gavage to male and female mice at dose levels of 25 – 200 mg/kg bw. Excretion of radioactivity in urine and faeces was followed in metabolism cages for a period of seven days and radioactivity in the carcass was determined at termination of the study. A number of animals at all dose groups except at 50 mg/kg bw died after dosing. However, there was no dose response and the cause of death could not be elucidated. Urinary excretion of radioactivity was low at all dose levels (0.6 %) and most of the radioactivity was found in faeces (77.9 %). The low recovery could not be attributed to retention in the body as the analysis of the carcass of animals with the lowest recoveries of radioactivity revealed that only 2.2 % of the dose remained in the body.
It is well known from other studies that chlorhexidine is bound to the mesenteric lymph nodes in which high amounts of chlorhexidine may be found. The preparation of the carcass is not described in detail in the present report. If the gut, or part of the gut, had been removed prior to the further processing and subsequent determination of radioactivity in the carcass, it seems likely that a portion of the radioactivity that could not be accounted for was removed with the mesenteric lymph nodes.
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